National foreword

This British Standard is the UK implementation of ISO 11040‑8:2016.

The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs.

A list of organizations represented on this committee can be obtained on request to its secretary.

This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 2016.

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.

The committee responsible for this document is ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use.

ISO 11040 consists of the following parts, under the general title Prefilled syringes:

Part 1: Glass cylinders for dental local anaesthetic cartridges
Part 2: Plunger stoppers for dental local anaesthetic cartridges
Part 3: Seals for dental local anaesthetic cartridges
Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
Part 5: Plunger stoppers for injectables
Part 6: Plastic barrels for injectables
Part 7: Packaging systems for sterilized subassembled syringes ready for filling
Part 8: Requirements and test methods for finished prefilled syringes

Introduction

Historically, injectable (parenteral) liquid pharmaceutical products have been mainly provided in primary containers (i.e. ampoules and vials) which required the liquid to be transferred into a hypodermic syringe and combined with the appropriate injection needle before its final use. This procedure is not only time-consuming, but also presents a great number of possibilities for contamination and use errors.

Over the past several years, the presentation of liquid pharmaceutical products in prefilled syringes for single use, many with staked needles, is becoming more prevalent. The simplicity of use that is provided not only benefits their use in the clinical setting, but also enables these to be used by lay users in a home setting.

The standardization of the requirements for prefilled syringes has been addressed by ISO/TC 76 in two ways:

the specification of the components of the prefilled syringe prior to filling is included in the previous parts of the ISO 11040 series;
the requirements for the final prefilled syringe, presented to the user as a finished product, are addressed in this part of ISO 11040.

Finished prefilled syringes require marketing authorization as a drug, in some regions as a combination product or as a medical device, depending on the content and the intended use. The syringe plays a dual role in the prefilled syringe product — as a container closure system and as a delivery device. Safety, performance and usability need to be considered, as well in case of intended preassembly, copackaging or label reference for use with other devices and equipment. This part of ISO 11040 addresses the content and syringe as a system, with the intent to ensure the successful performance for its intended purpose.

There are other international and national standards and guidance publications and, in some countries, national regulations that are applicable to medical devices and pharmaceuticals. Their requirements might supersede or complement this part of ISO 11040. Developers and manufacturers of finished prefilled syringes are encouraged to investigate and determine whether there are any other requirements relevant to the safety or marketability of their products.

1 Scope

This part of ISO 11040 is applicable to aseptically filled or terminally sterilized finished prefilled syringes (intended for single use only) based on ISO 11040‑4 or ISO 11040‑6, together with ISO 11040‑5, for parenteral injection preparations with focus on quality, functional performance and safety requirements, as well as relevant test methods.

Finished prefilled syringes which have undergone an additional preparation step by the user before injection (e.g. diluent syringes that have been emptied for reconstitution and in which the reconstituted drug solution has been aspirated after reconstitution) are excluded from the scope of this part of ISO 11040.

NOTE 1 This part of ISO 11040 can also be used as a guidance for other types, designs and/or sizes of prefilled syringes, e.g. dual chamber prefilled syringes.

NOTE 2 In case the finished prefilled syringes are used in a needle-based injection system, see also ISO 11608‑3.

NOTE 3 Attention is drawn to applicable national or regional regulations such as Ph. Eur1), USP2) or JP3).

NOTE 4 Finished prefilled syringes containing so-called borderline products, e.g. hyaluronic acid, are included in the scope of this part of ISO 11040, though they are not always regulated as a pharmaceutical product.

2 Normative references

3 Terms and definitions

4 User requirements

4.1 Definition of intended use

4.2 Risk management

4.3 Application of usability engineering

5 System characterization

5.1 Critical dimensions

5.2 Description of components and materials

5.3 Description of the content of the finished prefilled syringe

6 Performance requirements

6.1 General

6.2 Break loose and extrusion forces

6.3 Burst resistance

6.4 Break resistance

6.5 Closure system forces and torques

6.6 Connectivity with fluid path connectors

6.7 Residual volume

6.8 Needle penetration force

6.9 Needle pull-out force

6.10 Sharps injury protection requirements

6.11 Liquid leakage beyond plunger

6.12 Markings

7 Pharmaceutical requirements

7.1 General

7.2 Drug-container interaction

7.3 Biological requirements

7.4 Container closure integrity

7.5 Deliverable volume

7.6 Particles (visible and subvisible)

8 Documentation

Bibliography

BS ISO 11040-8:2016

Prefilled syringes - Requirements and test methods for finished prefilled syringes

Current, Under Review

Published:

30 Nov 2016